As is well known in the art, vitamins and minerals are required for the regulation of the body's metabolic functions, and are found naturally in the foods that we eat. Many foods are thus fortified in order to provide additional nutrients, or to replace nutrients that may have been lost during the processing of the food, and/or harvesting and/or storage.
Many people are able to obtain satisfactory nutrition from the wide selection of foods available in the United States. However, if a person's diet is nutritionally deficient or a special health condition exists, then a vitamin and mineral supplement from a secondary source is necessary.
Although people can, and in many instances do, obtain satisfactory nutrition from available food sources, many people ingest vitamin and/or mineral supplements as a “safety measure”. Unfortunately, the dosage of the vitamins and minerals ingested is often in excess of the body's requirements. As discussed below, large doses of vitamin and mineral supplements can, and in many instances will, adversely affect body function.
As is also well known in the art, there are several individual vitamins, which are required by the human body to maintain normal body function. These vitamins include vitamins A, C, D, E, K, Choline, and the members of the B vitamin group: vitamins B1 (thiamin), B2 (riboflavin), B6, B12, niacin and folate, biotin and pantothenic acid.
Vitamins are typically classified on the basis of their ability to dissolve in fat or in water. The fat-soluble vitamins, i.e. vitamins A, D, E, and K, are generally found in the fats of foods, nuts, vegetables and fruits.
In the event of excessive consumption of fat soluble vitamins, the excess will be stored in body fat tissues. This can lead to unwanted toxic buildup of certain vitamins; particularly, vitamins A, and D, and can cause teratogenic effects in the future (i.e. inherent birth defects in children).
Each of the fat-soluble vitamins performs a unique function in the body. Vitamin A is a very important fat-soluble vitamin. The functions of vitamin A include:                Vitamin A regulates the process of protein synthesis, promotes normal metabolism, plays an important role in the formation of bones and teeth, is responsible for the growth of new cells, and slows down the aging process.        Vitamin A is long-known for vital effects on eye sight. It ensures the normal activity of the visual analyzer and participates in the synthesis of visual pigment of the retina and the perception of the light beam by the eye.        Vitamin A is necessary for normal functioning of the immune system and is an integral part of the process of combating infections. Retinol is essential for the maintenance and restoration of epithelial tissues; which are made of skin and mucous integument.        Vitamin A has beneficial effects on lung function due to its close link with the mucous membrane and epithelial cells. Vitamin A is involved in the synthesis of the steroid hormones (including progesterone).        
Both Retinoids, a Vitamin A group, and Carotenoids are powerful antioxidants. They serve to protect cell membranes of the brain from the destructive effect of free radicals.
Vitamin D is another fat-soluble vitamin, which plays a role in the differentiation of cells in the intestines, skin, immune system, and bones. Vitamin D also regulates blood calcium levels, which are important in maintaining proper bone density.
A toxic or excess amount of vitamin D can similarly cause adverse organ function. The main consequence of vitamin D toxicity is a buildup of calcium in your blood (hypercalcemia), which can cause hard lumps of calcium in muscles and organs, heart rhythm abnormalities, kidney stones. Polyuria (i.e. frequent urination), muscle weakness, and nausea and gastro discomfort.
Although vitamin D toxicity is rare (even among people who take supplements), it has been found that the risk of vitamin D toxicity (and the adverse consequences resulting therefrom) is significantly greater for a person experiencing abnormal liver or kidney function or ingesting thiazide-type diuretics.
Vitamin E is another important fat-soluble vitamin, which is also considered and, hence, often referred to as an antioxidant. Vitamin E inserts itself into cell membranes and protects substances inside the cells, such as Deoxyribonucleic acid (DNA), from being chemically modified by oxygen-like molecules.
An excess amount of vitamin E can similarly cause adverse physiological consequences. Indeed, it is well known that excess amounts of vitamin E can, and in many instances will, increase the risk of bleeding (including bleeding within the brain, which can cause a stroke); particularly, for adults who are also ingesting an anticoagulant (especially Warfarin™). Adults who ingest excess amounts of vitamin E can also experience muscle weakness, fatigue, nausea, and diarrhea.
Vitamin K is involved in synthesizing proteins that help blood clot. Vitamin K is also necessary for producing a key protein that is important in bone formation. In addition to dietary sources, vitamin K can also be derived from bacteria that reside in the intestines.
A Mayo Clinic Report suggests that an adequate intake of vitamin K can cut the risk of non-Hodgkin's lymphoma by almost 50%.
The water-soluble vitamins include vitamin C and the B-complex family of vitamins. Water-soluble vitamins are not stored in the body and are generally excreted with urine when consumed in excess of the body's needs. However, as discussed below, prior to excretion, an excess amount of some water-soluble vitamins; particularly, vitamins B6 and B12, can cause a number of physiological complications.
Vitamin C's roles include assisting in the production and maintenance of collagen, a protein found in bones, skin, and teeth. Vitamin C is also known to prevent scurvy and plays a role in wound repair. It is essential for the development and maintenance of connective tissues, it protects your immune system and reduces the severity of allergic reactions.
The vitamin B family of vitamins, which include vitamins B1 (thiamine), B2 (riboflavin), B3 (niacin), vitamin B5 (pantothenic acid), B6 (pyridoxine), B7 (biotin), B9 (folic acid), B12 (cyanocobalamin), support many body functions.
Vitamin B1 aids in the conversion of carbohydrates into energy and maintains the mucus membranes in good condition. An excess amount of vitamin B1 can, however, cause skin rashes, hypersensitivity and high blood pressure.
Vitamin B2 aids in maintaining a strong immune system and regulates the growth of red blood cells; protects mucous membranes. Being a coenzyme, vitamin B2 is responsible for digestion of proteins and carbohydrates.
Vitamin B3 (niacin) is involved in enzyme reactions, aids in the metabolism of carbohydrates and prevents alopecia and certain gastrointestinal disorders. An excess of vitamin B3 can damage liver tissues, cause insomnia, heartburn, high blood sugar and vomiting.
There are numerous benefits of vitamin B6. Vitamin B6 aids in the formation of antibodies and strengthens the immune system. It's essential for getting energy and nutrients from food. Vitamin B6 is also responsible for the formation of vitamin B3 in the body.
Excess vitamin B6 can, however, adversely affect nerve function; particularly, nerves in the hands, feet and toes. Excess vitamin B6 can also cause high blood pressure, low blood sugar, formation of kidney stones, insomnia, cramps, headaches, fatigue and mood swings.
Vitamin B12 prevents pernicious anemia and supports the development and maturation of red blood cells. Vitamin B12 also helps in maintaining a healthy nervous system and aids in speeding up metabolism.
Excess vitamin B12 can, however, similarly adversely affect nerve function and, in some instances, cause panic attacks, heart palpitations or hyperthyroid.
As indicated above, various minerals are also required to maintain normal body function. The major minerals, which typically require more than 100 mg/day, include sodium, potassium, calcium, phosphorus, magnesium, sulfur, and chloride. The trace minerals, which require less than 100 mg/day, include iron, zinc, copper, selenium, iodine, chromium, manganese, fluoride, molybdenum, cobalt and others. Each of the noted minerals performs a unique function in the body.
The noted minerals cannot be made in the body and must be obtained from ingested food, water and supplements. However, as discussed below, an excess amount of one or more minerals can produce toxic effects.
Magnesium is an important mineral that helps the body to maintain muscles, nerves, and bones. It is also employed to maintain optimum heart rhythm, energy metabolism and protein synthesis.
A deficiency of magnesium can cause sensitiveness to noise, nervousness, irritability, mental depression, confusion, twitching, trembling, apprehension, insomnia, muscle weakness and cramps in the toes, feet, legs, or fingers.
Calcium is another important mineral that is essential for healthy and strong bones and teeth. Calcium also ensures the proper functioning of muscles and nerves, and aids in blood clotting.
A deficiency of calcium can thus adversely affect bone and teeth formation, while an excess of calcium can lead to adverse kidney function and stones.
Potassium serves as an electrolyte and is involved in the balance of fluid within the body. It is important in controlling the activity of the heart, muscles, nervous system and virtually every cell in the body. Potassium also regulates the water balance and acid-base balance in the blood and tissues.
A deficiency of potassium can cause abnormal muscle function, e.g. weak muscles. An excess of potassium can cause an irregular heartbeat.
Selenium is an essential mineral that functions largely in the form of proteins, i.e. seleno-proteins, which act as enzymes and help prevent damage to cells in the body by oxidants in the environment or those produced by normal metabolism.
A deficiency of selenium can cause “Keshan” disease; a fatal form of cardiomyopathy (heart muscle disease). While an excess of selenium can cause balding and brittle nails, intestinal distress, weakness and slowed mental functioning.
Zinc is another essential mineral. Zinc is involved in the manufacture of protein and in cell division, protects nerve and brain tissues.
A deficiency of zinc can cause short stature, anemia, increased pigmentation of skin, enlarged liver and spleen (hepatosplenomegaly), impaired gonadal function, impaired wound healing, and immune deficiency. An excess of zinc can cause gastrointestinal irritation (upset stomach) and cause copper deficiency.
Chromium works with insulin (a hormone, produced in the pancreas) in assisting cells to absorb glucose and release energy. Chromium picolinate, i.e. a form of chromium, is a mineral that plays a vital role in processing carbohydrates and fats.
A deficiency of chromium can cause anxiety, fatigue, glucose intolerance (particularly in people with diabetes), inadequate metabolism of amino acids, and an increased risk of arteriosclerosis. An excess amount of chromium can cause dermatitis, intestinal ulcers, and kidney and liver impairment.
Deficiencies of some of the aforementioned vitamins and minerals can thus adversely affect body function. It is thus important that a person provides his/her body with a sufficient intake of vitamins and minerals daily.
Various sources, such as Food and Nutrition Board, Institute of Medicine, National Academies, publish the recommended intake values for vitamins and minerals. Illustrative are the daily recommended vitamin intake charts shown in FIGS. 1A and 1B.
As indicated above, many people are able to obtain satisfactory nutrition and, hence, the daily recommended intake of essential vitamins and minerals from the wide selection of foods available in the United States. However, if a person's diet is nutritionally deficient, then a vitamin and mineral supplement from a secondary source is needed.
There are, however, several drawbacks and disadvantages associated with vitamin and/or mineral supplements from secondary sources. One major drawback is that few individuals are knowledgeable of their individual vitamin and mineral requirements and are often confused by the multitude of supplements available through secondary sources. As a result, very few individuals purchase and ingest the appropriate supplement. Moreover, many people consume more vitamins and or minerals that are needed.
A further major drawback is that most, if not all, vitamin supplements comprise unbalanced and/or excessive amounts of one or more vitamins. For example, as shown in Table 1 below, a vitamin supplement from one secondary source includes the following dosages of vitamins B1 and B2:
TABLE IVitaminDaily Dose% daily volumeB1 (Thiamin)50 mg3333%B2 (Riboflavin)50 mg2941%
The noted amounts of B vitamins can, and in most instances will, result in undesirable stress on organs to process and excrete the excess amounts of the B vitamins. Further, since B vitamins are interdependent, excess quantities of one B vitamin can adversely affect the bioactivity of other B vitamins and, in some instances, can produce a deficiency of other B vitamins or an allergic reaction.
Many supplements also contain various additional ingredients and minerals e.g., chromium, iron, manganese, selenium, potassium, etc. In many instances, the noted materials are similarly provided in unbalanced and/or excessive amounts that can be toxic.
As is well known in the art, many minerals, such as iron and chromium, can build up in the body and adversely affect organ function. For example, a toxic amount (e.g., ≧25 mg) or buildup of iron can cause liver and heart damage (atherosclerosis). As stated above, a toxic amount (e.g., ≧50 mg) or buildup of chromium can cause dermatitis, intestinal ulcers, and kidney and liver impairment.
A further major drawback associated with vitamin (and mineral) supplements from secondary sources is that the secondary sources do not account for (i) formulation compatibility, i.e. compatibility by and between supplement formulation components, e.g., individual vitamins, minerals, fillers, etc., (ii) physiological compatibility, i.e. compatibility by and between formulation components and the body, or (iii) medicinal compatibility, i.e. compatibility by and between formulation components and pharmacological agents, i.e. prescribed and over-the-counter medications.
As discussed in detail herein, compatibility issues by and between formulation components, formulation components and the body, and formulation components and pharmacological agents can, and in many instances will, adversely affect the bioavailability of one or more formulation components and/or pharmacological agents.
Compatibility issues by and between formulation components, formulation components and the body, and formulation components and pharmacological agents can, and in many instances will, also adversely affect body function.
Based on publicly available sources of information, zinc is known to decrease absorption of copper and competes for absorption with iron and calcium, and calcium and iron reduce the absorption of manganese, thus combining in one pill or capsule specified minerals impose the need for an increased daily dosage in order to meet the daily norms. It is a known fact that not all of the vitamins and minerals are compatible with each other during prolonged storage and during the period of absorption time inside the human body.
Further, patients with diseases of the heart and blood vessels are often prescribed blood-thinning pharmacological agents or medications, such as Coumadin™ and Warfarin™. Vitamin K can interfere with such drugs.
While very low levels of vitamin K in the body can result in poor clot formation and increased bleeding, very high doses of ingested or administered vitamin K may act to counteract large doses of anticoagulants, placing the patient at risk for clot formation. Similarly, high levels of vitamin C (ascorbic acid) may interfere with anticoagulant inhibition of the clotting pathway and lead to increased risk for clot formation.
Many types of pharmacological agents that are used in the treatment of high blood pressure can also interact with high levels of supplemented vitamins. For example, antihypertensive pharmacological agents, which help lower blood pressure by dilating blood vessels, can be affected by increased levels of vitamin B3 (niacin). In high doses (>75 mg), niacin may dilate blood vessels and heighten the medication effects, resulting in dangerously low blood pressure. Digitalis-based drugs, such as Digoxin™ and Diltiazem™, can also be affected by vitamin D via alteration in blood calcium level and can induce irregular heartbeats, i.e. arrhythmias.
Other pharmacological agents, which treat high blood pressure by decreasing the amount of fluid in the body, called diuretics, can also be affected by vitamins. Thiazide diuretics act on the kidney to remove fluid, but retain minerals, such as calcium. Excessive vitamin D ingestion while on diuretic therapy can result in increased calcium in the blood. As in other vitamin D-drug interactions, increased blood calcium can also cause abnormal heartbeats, i.e. arrhythmias.
It would thus be desirable to provide a system and method for determining compatibility by and between supplement formulation components, formulation components and the body, and formulation components and pharmacological agents.
It is therefore an object of the present invention to provide a system and method for determining compatibility by and between supplement formulation components, formulation components and the body, and formulation components and pharmacological agents.
It is another object of the invention to provide a system and method for determining compatibility by and between supplement formulation components, formulation components and the body, and formulation components and pharmacological agents that can be tailored to an individual's specific physiology.
It is another object of the invention to provide a system and method for determining compatibility by and between supplement formulation components, formulation components and the body, and formulation components and pharmacological agents that is adapted to wirelessly receive and transmit data and information from/to a skilled party, e.g., physician or nutritionist.
It is another object of the invention to provide bioactive formulations and supplements based on determined compatibility by and between supplement formulation components, formulation components and the body, and formulation components and pharmacological agents that can be tailored to an individual's specific physiology.